Software Requirements Specification Template

---
title: "Software Requirements Specification Template"
methodology: "universal"
complexity: "advanced"
owner: "mirichard"
updated: "2026-09-19"
primary_principles: ["quality-by-design"]
secondary_principles: ["evidence-based-decisions", "stewardship"]
principle_rationale: "Traces regulated software intended use, functional requirements and controls to agreed testing and validation acceptance criteria."
---

# Software Requirements Specification (SRS) Template

## When to Use

- When regulated software needs traceable intended-use, functional, and control requirements.
- When qualified owners must connect requirements to acceptance and validation evidence.

## When NOT to Use

- To approve regulated use based on a specification without validation evidence.
- Do not represent author self-checks as independent or authorized approval. See [Self-approval](../../../../../docs/principles/anti-patterns.md#self-approval).

## Pairs Well With

- [Computer System Validation Protocol Template](../../../../../domains/delivery/industry-specializations/healthcare-pharmaceutical/regulatory/computer_system_validation_protocol_template.md).
- [Requirements Traceability Matrix Template](../../../../../domains/delivery/templates/traditional/Traditional/Process_Groups/Executing/requirements_traceability_matrix_template.md).

Selection context: Delivery domain; universal methodology; advanced complexity. Match the situations above to project phase, risk, team size, and industry using the [decision-engine context model](../../../../../meta/architecture-research/800-801-context-assessment-model.md).

## Applying this template

Treat filled examples, dates, numerical limits, sampling frequencies, and approval outcomes as illustrations. Before execution, replace them with the approved product/site requirements, scientific rationale, method references, responsible reviewer, and acceptance evidence. Record the applicable jurisdiction and current guidance edition; a completed worksheet alone does not demonstrate regulatory compliance.

| Requirement or limit | Applicable source / edition | Product-specific rationale | Approval / date | Execution evidence |
|---|---|---|---|---|
| [Requirement] | [Source] | [Rationale] | [Reviewer / date] | [Record] |


## Document Control

| Document Information | Details |
|---------------------|---------|
| Document Number | SRS-XXX-VERSION |
| Version | 1.0 |
| Effective Date | [INSERT DATE] |
| Review Period | [INSERT PERIOD, e.g., 12 months] |
| Supersedes | None |
| Prepared By | [NAME, ROLE] |
| Reviewed By | [NAME, ROLE] |
| Approved By | [NAME, ROLE] |

### Revision History

| Version | Date | Description of Changes | Author | Approved By |
|---------|------|------------------------|--------|------------|
| 1.0 | [DATE] | Initial release | [AUTHOR] | [APPROVER] |

### Distribution List

| Department/Role | Name | Date Distributed |
|----------------|------|------------------|
| IT | | |
| Quality Assurance | | |
| Validation | | |
| Regulatory Affairs | | |
| End Users | | |

## 1. Introduction

### 1.1 Purpose
This Software Requirements Specification (SRS) document describes the functional and non-functional requirements for [SYSTEM NAME], version [VERSION NUMBER]. This document establishes the basis for agreement between users, sponsors, and the development team on what the system should do.

### 1.2 Scope
This SRS applies to the [SYSTEM NAME] system, which will be used for [PRIMARY FUNCTION]. The system will be used by [USER GROUPS] in [DEPARTMENT/ORGANIZATION] to [DESCRIBE ACTIVITIES].

### 1.3 System Overview
[SYSTEM NAME] is a [TYPE OF SYSTEM, e.g., laboratory information management system, clinical data management system, etc.] designed to [BRIEF DESCRIPTION OF SYSTEM PURPOSE]. The system will interact with [LIST INTEGRATED SYSTEMS] and will be used in a GxP-regulated environment, necessitating validation according to [RELEVANT REGULATIONS AND GUIDELINES].

### 1.4 Definitions, Acronyms, and Abbreviations

| Term/Acronym | Definition |
|--------------|------------|
| SRS | Software Requirements Specification |
| URS | User Requirements Specification |
| GxP | Good [x] Practice (where x can be Manufacturing, Laboratory, Clinical, etc.) |
| GAMP | Good Automated Manufacturing Practice |
| 21 CFR Part 11 | FDA regulations on Electronic Records and Electronic Signatures |
| EU Annex 11 | European Union GMP guidelines for computerized systems |
| [ADD ADDITIONAL TERMS] | |

### 1.5 References

1. [REFERENCE DOCUMENT 1, e.g., User Requirements Specification for (System Name)]
2. [REFERENCE DOCUMENT 2, e.g., Corporate Validation Policy]
3. FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures
4. EU GMP Annex 11 - Computerized Systems
5. GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
6. [ADD ADDITIONAL REFERENCES]

## 2. System Architecture and Components

### 2.1 System Context Diagram
[PROVIDE A DIAGRAM OR DESCRIPTION OF THE SYSTEM IN CONTEXT WITH OTHER SYSTEMS AND USERS]

### 2.2 System Components
The system consists of the following major components:

1. [COMPONENT 1, e.g., User Interface Module] - [BRIEF DESCRIPTION]
2. [COMPONENT 2, e.g., Database] - [BRIEF DESCRIPTION]
3. [COMPONENT 3, e.g., Reporting Engine] - [BRIEF DESCRIPTION]
4. [COMPONENT 4, e.g., Integration Services] - [BRIEF DESCRIPTION]
5. [ADD ADDITIONAL COMPONENTS AS NEEDED]

### 2.3 Deployment Architecture
[DESCRIBE THE HARDWARE AND NETWORK ARCHITECTURE, INCLUDING SERVERS, CLIENTS, AND COMMUNICATION PATHS]

### 2.4 Development and Test Environments
[DESCRIBE THE ENVIRONMENTS REQUIRED FOR DEVELOPMENT, TESTING, VALIDATION, AND PRODUCTION]

## 3. Functional Requirements

### 3.1 User Interface Requirements

#### 3.1.1 General UI Requirements
- **Req-UI-001**: The system shall provide a browser-based interface accessible via [SUPPORTED BROWSERS].
- **Req-UI-002**: The system shall support a responsive design that functions on [SUPPORTED DEVICES/SCREEN SIZES].
- **Req-UI-003**: The user interface shall comply with [ACCESSIBILITY STANDARDS] for accessibility.
- **Req-UI-004**: The system shall support [LANGUAGES] for all user interface elements.
- **Req-UI-005**: Error messages shall be clear, descriptive, and provide guidance for resolution.

#### 3.1.2 User Authentication and Authorization
- **Req-UI-006**: The system shall require user authentication with unique username and password.
- **Req-UI-007**: The system shall support role-based access control with the following roles: [LIST ROLES].
- **Req-UI-008**: The system shall enforce password complexity requirements per [REFERENCE SECURITY POLICY].
- **Req-UI-009**: The system shall automatically log out inactive users after [TIME PERIOD].
- **Req-UI-010**: The system shall maintain an audit trail of all login attempts, both successful and failed.

#### 3.1.3 Screen-Specific Requirements
[LIST SPECIFIC SCREENS AND THEIR REQUIREMENTS]

### 3.2 Data Management Requirements

#### 3.2.1 Data Entry and Validation
- **Req-DM-001**: The system shall validate data entries according to predefined rules for each field.
- **Req-DM-002**: The system shall prevent the submission of forms with invalid or incomplete required data.
- **Req-DM-003**: The system shall support automated data import from [LIST SOURCES] in [LIST FORMATS].
- **Req-DM-004**: The system shall maintain data integrity through [DESCRIBE MECHANISMS].
- **Req-DM-005**: The system shall provide data entry templates for [LIST PROCESSES].

#### 3.2.2 Data Storage
- **Req-DM-006**: The system shall store all data in a relational database with [SPECIFIC REQUIREMENTS].
- **Req-DM-007**: The database shall be designed to ensure data integrity through referential integrity constraints.
- **Req-DM-008**: The system shall retain all data for a minimum of [TIME PERIOD] in accordance with [REGULATORY REQUIREMENTS].
- **Req-DM-009**: The system shall support data archiving for records older than [TIME PERIOD].
- **Req-DM-010**: The system shall maintain a complete audit trail of all data changes.

#### 3.2.3 Data Retrieval and Search
- **Req-DM-011**: The system shall provide search functionality by [LIST SEARCH CRITERIA].
- **Req-DM-012**: The system shall support filtering and sorting of data by [LIST CRITERIA].
- **Req-DM-013**: The system shall provide advanced search capabilities including [DESCRIBE CAPABILITIES].
- **Req-DM-014**: Search results shall be exportable in [LIST FORMATS].
- **Req-DM-015**: The system shall provide a mechanism for saved searches.

### 3.3 Process Flow Requirements

#### 3.3.1 Workflow Management
- **Req-PF-001**: The system shall support the following workflows: [LIST WORKFLOWS].
- **Req-PF-002**: Each workflow shall include configurable approval steps.
- **Req-PF-003**: The system shall notify appropriate users when their action is required in a workflow.
- **Req-PF-004**: The system shall enforce segregation of duties in critical workflows.
- **Req-PF-005**: The system shall provide workflow status visibility to authorized users.

#### 3.3.2 Business Rules
- **Req-PF-006**: The system shall enforce business rules for [DESCRIBE PROCESSES].
- **Req-PF-007**: Business rules shall be configurable by system administrators.
- **Req-PF-008**: The system shall maintain an audit trail of business rule changes.
- **Req-PF-009**: The system shall validate data against business rules before processing.
- **Req-PF-010**: The system shall provide feedback when business rules prevent an action.

### 3.4 Reporting Requirements

#### 3.4.1 Standard Reports
- **Req-RP-001**: The system shall provide the following standard reports: [LIST REPORTS].
- **Req-RP-002**: Standard reports shall be accessible to users with appropriate permissions.
- **Req-RP-003**: Report data shall be filterable by [LIST CRITERIA].
- **Req-RP-004**: Reports shall be available in the following formats: [LIST FORMATS].
- **Req-RP-005**: Reports shall include appropriate headers, footers, and pagination.

#### 3.4.2 Ad Hoc Reporting
- **Req-RP-006**: The system shall provide an ad hoc reporting tool for authorized users.
- **Req-RP-007**: The ad hoc reporting tool shall support [DESCRIBE CAPABILITIES].
- **Req-RP-008**: Users shall be able to save custom report definitions for future use.
- **Req-RP-009**: The system shall restrict ad hoc reporting to data the user is authorized to access.
- **Req-RP-010**: Ad hoc reports shall be exportable in [LIST FORMATS].

#### 3.4.3 Dashboards
- **Req-RP-011**: The system shall provide configurable dashboards for key metrics.
- **Req-RP-012**: Dashboards shall be role-specific and configurable by administrators.
- **Req-RP-013**: Dashboard components shall refresh automatically every [TIME PERIOD].
- **Req-RP-014**: Users shall be able to drill down from dashboard metrics to detailed data.
- **Req-RP-015**: Dashboard configurations shall be saved on a per-user basis.

### 3.5 Interface Requirements

#### 3.5.1 System Interfaces
- **Req-IF-001**: The system shall interface with [SYSTEM 1] using [PROTOCOL/METHOD].
- **Req-IF-002**: The system shall interface with [SYSTEM 2] using [PROTOCOL/METHOD].
- **Req-IF-003**: All interfaces shall validate data before processing.
- **Req-IF-004**: All interfaces shall maintain a transaction log.
- **Req-IF-005**: The system shall handle interface errors through [DESCRIBE METHOD].

#### 3.5.2 User Interfaces
- **Req-IF-006**: The system shall provide the following user interfaces: [LIST INTERFACES].
- **Req-IF-007**: All user interfaces shall follow the corporate UI style guide.
- **Req-IF-008**: User interfaces shall be consistent in layout and navigation.
- **Req-IF-009**: The system shall provide context-sensitive help for all interfaces.
- **Req-IF-010**: The system shall support keyboard shortcuts for common operations.

#### 3.5.3 Data Import/Export
- **Req-IF-011**: The system shall support data import from [LIST SOURCES] in [LIST FORMATS].
- **Req-IF-012**: The system shall validate imported data before processing.
- **Req-IF-013**: The system shall support data export in [LIST FORMATS].
- **Req-IF-014**: Exported data shall include relevant metadata.
- **Req-IF-015**: The system shall maintain a log of all import and export operations.

## 4. Non-Functional Requirements

### 4.1 Performance Requirements
- **Req-NF-001**: The system shall support a minimum of [NUMBER] concurrent users.
- **Req-NF-002**: The system shall respond to user input within [TIME] seconds for [PERCENTAGE]% of operations.
- **Req-NF-003**: Reports shall generate within [TIME] seconds for [DESCRIBE SCOPE].
- **Req-NF-004**: The system shall process [NUMBER] transactions per [TIME PERIOD].
- **Req-NF-005**: Database queries shall complete within [TIME] seconds for [PERCENTAGE]% of operations.

### 4.2 Security Requirements

#### 4.2.1 Access Control
- **Req-SEC-001**: The system shall enforce role-based access control.
- **Req-SEC-002**: The system shall support the principle of least privilege.
- **Req-SEC-003**: The system shall enforce password policies in accordance with [POLICY REFERENCE].
- **Req-SEC-004**: The system shall support multi-factor authentication for [ROLES/FUNCTIONS].
- **Req-SEC-005**: The system shall automatically lock accounts after [NUMBER] failed login attempts.

#### 4.2.2 Data Protection
- **Req-SEC-006**: The system shall encrypt sensitive data in transit using [PROTOCOL].
- **Req-SEC-007**: The system shall encrypt sensitive data at rest using [ALGORITHM].
- **Req-SEC-008**: The system shall mask or obfuscate sensitive data in displays and reports as appropriate.
- **Req-SEC-009**: The system shall prevent unauthorized data extraction.
- **Req-SEC-010**: The system shall implement appropriate controls for handling sensitive data.

#### 4.2.3 Audit and Monitoring
- **Req-SEC-011**: The system shall maintain an audit trail of all system activities.
- **Req-SEC-012**: Audit trails shall include user ID, date/time, activity type, and affected data.
- **Req-SEC-013**: Audit trails shall be protected from unauthorized modification or deletion.
- **Req-SEC-014**: The system shall support monitoring and alerting for security events.
- **Req-SEC-015**: The system shall provide audit reports for regulatory compliance.

### 4.3 Compliance Requirements

#### 4.3.1 21 CFR Part 11 Compliance
- **Req-COMP-001**: The system shall maintain accurate, complete electronic records.
- **Req-COMP-002**: The system shall ensure electronic records remain readable and retrievable throughout their retention period.
- **Req-COMP-003**: The system shall use secure, computer-generated, time-stamped audit trails.
- **Req-COMP-004**: The system shall enforce electronic signature components, including username and password.
- **Req-COMP-005**: The system shall record the meaning of electronic signatures (e.g., review, approval).

#### 4.3.2 EU Annex 11 Compliance
- **Req-COMP-006**: The system shall provide adequate controls to ensure the accuracy, reliability, and consistent performance of computerized systems.
- **Req-COMP-007**: The system shall include risk management throughout the lifecycle.
- **Req-COMP-008**: The system shall ensure that data is securely stored with appropriate backup.
- **Req-COMP-009**: The system shall implement appropriate change control procedures.
- **Req-COMP-010**: The system shall support periodic evaluation to confirm continued GMP compliance.

#### 4.3.3 GAMP 5 Alignment
- **Req-COMP-011**: The system shall be categorized according to GAMP 5 guidelines.
- **Req-COMP-012**: The system shall follow a lifecycle approach to validation.
- **Req-COMP-013**: The system shall implement quality risk management principles.
- **Req-COMP-014**: The system shall comply with GAMP 5 documentation requirements.
- **Req-COMP-015**: The system shall support a risk-based approach to validation.

### 4.4 Data Integrity Requirements
- **Req-DI-001**: The system shall implement ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
- **Req-DI-002**: The system shall prevent unauthorized changes to data.
- **Req-DI-003**: The system shall maintain complete metadata for all records.
- **Req-DI-004**: The system shall enforce data entry validation rules.
- **Req-DI-005**: The system shall maintain data relationships and referential integrity.

### 4.5 Backup and Recovery Requirements
- **Req-BR-001**: The system shall be backed up [FREQUENCY] according to [BACKUP STRATEGY].
- **Req-BR-002**: The system shall support point-in-time recovery to within [TIME PERIOD].
- **Req-BR-003**: Backup media shall be stored [DESCRIBE STORAGE REQUIREMENTS].
- **Req-BR-004**: The system shall support disaster recovery procedures with a recovery time objective of [TIME].
- **Req-BR-005**: Backup and recovery procedures shall be tested [FREQUENCY].

## 5. System Environment Requirements

### 5.1 Hardware Requirements
- **Req-ENV-001**: The system shall run on [SPECIFY SERVER HARDWARE REQUIREMENTS].
- **Req-ENV-002**: Client workstations shall meet the following minimum specifications: [LIST SPECIFICATIONS].
- **Req-ENV-003**: The system shall support [SPECIFY PERIPHERALS] as input/output devices.
- **Req-ENV-004**: The production environment shall include redundant components for [LIST COMPONENTS].
- **Req-ENV-005**: The system shall be accessible from [DESCRIBE LOCATIONS/NETWORK REQUIREMENTS].

### 5.2 Software Requirements
- **Req-ENV-006**: The system shall run on [OPERATING SYSTEM(S) AND VERSION(S)].
- **Req-ENV-007**: The system shall use [DATABASE PLATFORM AND VERSION].
- **Req-ENV-008**: The system shall require the following additional software: [LIST SOFTWARE].
- **Req-ENV-009**: The system shall be compatible with [SPECIFY BROWSERS AND VERSIONS].
- **Req-ENV-010**: The system shall support integration with [ENTERPRISE SYSTEMS].

### 5.3 Network Requirements
- **Req-ENV-011**: The system shall operate on a network with minimum bandwidth of [SPECIFY].
- **Req-ENV-012**: The system shall support [SPECIFY PROTOCOLS].
- **Req-ENV-013**: Network communication shall be encrypted using [SPECIFY PROTOCOL].
- **Req-ENV-014**: The system shall be accessible through [SPECIFY NETWORK CONFIGURATIONS].
- **Req-ENV-015**: The system shall implement appropriate network security controls.

## 6. Testing and Acceptance Criteria

### 6.1 Testing Approach
[DESCRIBE THE OVERALL TESTING STRATEGY, INCLUDING TYPES OF TESTING TO BE PERFORMED]

### 6.2 Test Environments
[DESCRIBE THE TEST ENVIRONMENTS REQUIRED AND THEIR CONFIGURATIONS]

### 6.3 Acceptance Criteria
The system shall be considered acceptable when:

1. All requirements labeled as "Critical" or "High" priority are fully implemented and tested.
2. System performance meets or exceeds the performance requirements specified in Section 4.1.
3. The system passes all compliance-related tests for 21 CFR Part 11 and EU Annex 11.
4. User acceptance testing is completed with no critical or high-priority defects outstanding.
5. All documentation is complete and approved.

### 6.4 Traceability
Each requirement shall be traceable to test cases that verify its implementation. The Requirements Traceability Matrix (Section 7) shall be maintained throughout the project lifecycle.

## 7. Traceability Matrix

| Req ID | Requirement Description | Priority | Risk Level | Test Case ID | Verification Method | Status |
|--------|-------------------------|----------|------------|--------------|---------------------|--------|
| Req-UI-001 | [DESCRIPTION] | [PRIORITY] | [RISK] | [TEST CASE] | [METHOD] | [STATUS] |
| Req-DM-001 | [DESCRIPTION] | [PRIORITY] | [RISK] | [TEST CASE] | [METHOD] | [STATUS] |
| [CONTINUE FOR ALL REQUIREMENTS] | | | | | | |

## 8. Appendices

### Appendix A: Glossary of Terms
[PROVIDE A COMPREHENSIVE GLOSSARY OF TERMS USED IN THE DOCUMENT]

### Appendix B: Business Process Diagrams
[INCLUDE RELEVANT BUSINESS PROCESS DIAGRAMS THAT THE SYSTEM WILL SUPPORT]

### Appendix C: Data Dictionary
[PROVIDE A DATA DICTIONARY DEFINING ALL DATA ELEMENTS]

### Appendix D: Use Cases
[PROVIDE DETAILED USE CASES FOR KEY SYSTEM FUNCTIONS]

### Appendix E: Screen Mockups
[INCLUDE MOCKUPS OR PROTOTYPES OF KEY SCREENS]

### Appendix F: Regulatory References
[PROVIDE DETAILED REFERENCES TO RELEVANT REGULATIONS AND GUIDELINES]

## Approval

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Project Sponsor | | | |
| Quality Assurance | | | |
| Validation Lead | | | |
| IT Representative | | | |
| End User Representative | | | |